Pharmaceutical Quality Assurance Notes | B Pharmacy 6th Semester Imperfect Pharmacy Notes

Imperfect Pharmacy
B Pharmacy
Notes

 6th Semester 

PHARMACEUTICAL QUALITY ASSURANCE

Unit 1

Quality Assurance and Quality Management concepts: Definition and concept of Qualitycontrol, Quality assurance and GMP

Total Quality Management (TQM): Definition, elements, philosophies

ICH Guidelines: purpose, participants, process of harmonization, Brief overview of QSEM, with special emphasis on Q-series guidelines, ICH stability testing guidelines

Quality by design (QbD): Definition, overview, elements of QbD program, tools

ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration

NABL accreditation: Principles and procedures

OPEN UNIT 1

Unit 2

Organization and personnel: Personnel responsibilities, training, hygiene and personal

records. Premises: Design, construction and plant layout, maintenance, sanitation,

environmental control, utilities and maintenance of sterile areas, control of contamination.

Equipments and raw materials: Equipment selection, purchase specifications,

maintenance, purchase specifications and maintenance of stores for raw materials.

OPEN UNIT 2 

Unit 3

Quality Control: Quality control test for containers, rubber closures and secondary packing material

Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities, Equipment, Testing Facilities Operation, and Control Articles, Protocol for Conduct of aNonclinical Laboratory Study, Records and Reports, Disqualification of Testing Facilities

OPEN UNIT 3

Unit 4

Complaints: Complaints and evaluation of complaints, Handling of return good, recalling

and waste disposal.

Document maintenance in pharmaceutical industry: Batch Formula Record, Master

Formula Record, SOP, Quality audit, Quality Review and Quality documentation, Reports and

documents, distribution records.

OPEN UNIT 4

Unit 5

Calibration and Validation: Introduction, definition and general principles of calibration,

qualification and validation, importance and scope of validation, types of validation, validation

master plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General

principles of Analytical method Validation.

Warehousing: Good warehousing practice, materials management.

OPEN UNIT 5